New Study Explores Efficacy of Photodynamic Therapy in Adolescents Undergoing Orthodontic Treatment

Lund, Sweden – A new clinical study, "Efficacy of Regular Home Use of Dual-Light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment", is underway at Borgska Villan's Specialist Dental Care clinic in Lund, Sweden. The so-called Clean Bracket study evaluates the effectiveness of the antibacterial Lumoral method in improving oral health for teenagers with fixed braces.

The study, led by associate professor at Malmö University and former president of the Swedish Society of Periodontology and Implantology, Dr Ann-Marie Roos Jansåker, in collaboration with specialist orthodontist Dr Katja Elses, focuses on determining whether regular use of the light-activated Lumoral teeth cleaning method can help reduce plaque buildup and prevent gingival inflammation and caries, common issues faced by individuals with braces.

"The study explores how Lumoral's cutting-edge technology can significantly enhance oral health for adolescents with fixed braces, a treatment known for complicating daily oral hygiene. Braces can make it challenging to remove biofilm—a bacterial layer on the teeth—which can lead to gum inflammation and cavities. This research aims to provide robust evidence on how the regular use of Lumoral's light-activated therapy can effectively mitigate these risks and improve overall dental health during orthodontic treatment," explains Koite Health Clinical Project Manager Mikko Kylmänen.

According to Mr Kylmänen, the study received ethical approval in April 2023 and permission from Läkemedelsverket (the Swedish Medical Products Agency) in June 2023. It began enrolling its first patients in November 2023. 

In a clinical study with 40 subjects undergoing orthodontic treatment, participants are randomised into either the Lumoral treatment group or a control group. Over 12 weeks, clinical measurements like visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) will be assessed, alongside microbiological analyses to evaluate the device's effectiveness. The last patient's visit is expected to take place in the autumn of 2024, and the trial's final results are anticipated in the early spring of 2025. 

Study Background and Purpose

The Clean Bracket study led by Dr Roos Jansåker is mainly focused on adolescents aged 15 to 18 undergoing orthodontic treatment, a group at heightened risk of plaque buildup and gingival inflammation due to the challenges posed by fixed braces. The trial aims to determine whether light-activated antibacterial treatment can improve plaque control and aid in managing plaque over time. The Lumoral device, developed by Finnish scientists, may also have a photobiomodulation (PBM) effect, potentially benefiting periodontal tissue health. (1, 2)

PBM is a noninvasive therapy that has demonstrated positive effects in neurosensory recovery, treating musculoskeletal injuries and degenerative diseases, and promoting healing in regenerative medicine and dentistry. In dentistry, PBM enhances cellular activity, aiding bone regeneration and stimulating soft tissues. It improves wound healing, reduces postoperative pain, and enhances periodontal treatment outcomes, improving patient comfort and efficacy. Despite its potential, its use in dentistry has been limited.

Research in PBM has grown rapidly in recent years, with an increasing focus on low-level laser therapy and new technologies like laser diodes in dentistry. The field has evolved from early topics like aiding in the healing of dentine and surrounding tissues and improving outcomes in dental treatments like cavity fillings or root canal therapy to more complex treatments, such as tissue regeneration and cell therapy using dental pulp stem cells. New research areas, including the detection of early-stage caries, are emerging rapidly. These lasers can identify changes in tooth structure by measuring how light interacts with enamel and dentine, helping detect caries early.

PBM is a therapeutic process that uses light, typically low-level lasers or LEDs, to stimulate cellular function, promote healing, reduce inflammation, and alleviate pain. PBM delivers specific wavelengths of light to cells, which are absorbed by mitochondria (the energy-producing structures within cells). This absorption increases cellular energy production (ATP), enhancing tissue repair and regeneration. (1, 2)

According to Dr Roos Jansåker, orthodontic treatment is common among children and adolescents, but fixed appliances make maintaining oral hygiene challenging. Poor oral hygiene, on the other hand, attracts significant dental plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur. Patients with fixed orthodontic treatment appliances also have an increased risk of caries and gingivitis.

"Orthodontic treatments, such as braces, are essential for correcting dental alignment in teenagers, but they also come with certain risks that must be addressed. We hope to demonstrate that regular antibacterial treatment can significantly benefit adolescents wearing fixed orthodontic appliances," Dr Roos Jansåker said.

According to the associate professor, one of the most significant risks associated with braces is the development of cavities.

"This is particularly concerning for teenagers who often consume a lot of sugary drinks like Coca-Cola and eat candy, and their oral hygiene practices might not be as rigorous as needed, increasing the likelihood of caries development."

While more severe periodontal problems, like periodontitis (which involves the breakdown of bone around the teeth), are uncommon in teenagers, Dr Roos Jansåker stressed that gingivitis is a frequent issue.

"Gingivitis is a superficial inflammation of the gums caused by plaque buildup, and it is prevalent among teens with braces. Teenagers mustn't have gingivitis before getting braces because it can worsen during treatment. This is why maintaining healthy gums is so important already before starting orthodontic treatment."

Another significant problem associated with braces is the development of white spots on the teeth. These white areas on tooth enamel, which appear when the braces are removed, result from plaque buildup that leads to enamel demineralisation due to acid exposure.

"This is a serious concern because these spots can be permanent and affect the appearance of the teeth," Dr Roos Jansåker explained.

Antibacterial treatment

Lumoral is a CE-marked medical device designed to improve oral health by targeting and reducing harmful bacterial plaque through its light-activated antibacterial technology. The device combines antibacterial blue and red light, along with a photosensitive Lumorinse mouth rinse, to kill bacteria in the mouth and reduce plaque buildup. It is beneficial for individuals with orthodontic appliances, gum disease, or those prone to plaque-related oral issues.

"If a device like Lumoral can demonstrate its effectiveness in reducing plaque around braces, it could be an excellent tool to minimise these risks. The results from follow-up checks, especially at the three-month mark, are crucial in assessing the device's impact on plaque control. Consistent monitoring and good oral hygiene practices are essential to prevent these common issues associated with orthodontic treatment," Dr Roos Jansåker pointed

"We look forward to the final results of this study, as it represents a significant advancement in improving oral care routines for adolescents. Previous studies with Lumoral have consistently shown that it effectively reduces plaque and inflammation in the mouth. Feedback from the field indicates that Lumoral is also an effective aid for adolescents undergoing orthodontic treatment," concludes Mikko Kylmänen from Koite Health..

Rodriguez Salazar DY, Málaga Rivera JA, Laynes Effio JE, Valencia-Arias A. A systematic review of trends in photobiomodulation in dentistry between 2018 and 2022: advances and investigative agenda. F1000Res. 2023 Dec 28;12:1415. doi: 10.12688/f1000research.140950.2. PMID: 38288260; PMCID: PMC10823425.

Dompe C, Moncrieff L, Matys J, Grzech-Leśniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwińska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724. PMID: 32503238; PMCID: PMC7356229.

Contact:

Mikko Kylmänen
Clinical Project Manager, Koite Health
+358 40 724 5934
[email protected]